To execute and manage commissioning, qualification, and validation (CQV) activities for equipment, utilities, and systems at client sites in accordance with GxP, regulatory, and project requirements. The role involves ensuring compliance with applicable standards (ISPE Baseline Guides, ASTM E2500, EU Annex 15, 21 CFR Part 11) and supporting project delivery by providing technical expertise and documentation in line with client procedures.
CQV Execution and Documentation
- Prepare, review, and execute CQV documentation including URS, DQ, FAT/SAT, IQ/OQ/PQ protocols, summary reports, and related deliverables.
- Perform commissioning and qualification testing in accordance with approved procedures and project schedules.
- Ensure traceability of all qualification activities and maintain data integrity in documentation.
- Participate in risk assessments, change control processes, and deviation management related to qualified systems.
- Support development of test scripts and acceptance criteria for mechanical, electrical, automation, and process systems.
- Verify that systems meet design and regulatory requirements prior to release for GMP use.
Compliance and Quality Support
- Ensure all activities comply with regulatory expectations and client quality systems.
- Support internal and external audits by providing documentation and technical explanations as required.
- Maintain accurate, complete, and auditable documentation in compliance with GDP (Good Documentation Practices).
- Participate in continuous improvement initiatives for CQV procedures and documentation templates.
Client & Project Support
- Serve as the technical point of contact for assigned systems, providing status updates and issue resolutions to the client.
- Collaborate effectively with client functions including Quality Assurance, Manufacturing, Engineering, and Facilities to align CQV activities with operational readiness.
- Supervise and coordinate the work of third-party vendors and contractors during equipment commissioning and qualification.
- Report project progress, risks, and deviations to the Project Manager or CQV Lead on a regular basis.
- Ensure all work is performed in compliance with client EHS, quality, and data handling requirements.
